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Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB

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ClinicalTrials.gov Identifier: NCT02348177
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 3, 2014
January 28, 2015
May 11, 2017
January 2013
December 2016   (Final data collection date for primary outcome measure)
Modelled C0/morning trough [ Time Frame: Predose ]
Proportions of children treated with modelled lopinavir morning C0/morning trough <1mg/L at each of the intensive PK evaluations.
Same as current
Complete list of historical versions of study NCT02348177 on ClinicalTrials.gov Archive Site
  • C0/morning trough [ Time Frame: Predose ]
    Proportions of children with observed lopinavir morning trough, C0/morning trough <1mg/L at each of the intensive PK evaluations
  • ALT [ Time Frame: baseline, PK1, PK2, PK3 ]
    Safety and tolerability of superboosting focusing on liver functions through clinical and biochemical monitoring.
  • ECG [ Time Frame: baseline, 2 weeks after LPV/r 1:1, PK1 ]
    Potential superboosting cardiac effect monitored by electrocardiogram at the beginning of anti-TB and HIV concomitant therapy
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Lopinavir/Ritonavir Superboosting in Infants and Young Children Co-infected With HIV and TB
A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.
The purpose of this study is to determine the lopinavir levels in blood of HIV and TB infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing TB regimen and its safety.

This is a multicentre, open label, non-randomized, prospective, noninferiority study to compare the pharmacokinetics of lopinavir administered with superboosting (LPV/r 1:1) and concurrent RIF treatment or with standard boosting (LPV/r 4:1) without concurrent RIF treatment, and to assess the safety, tolerance, and virological effect of superboosting in HIV-TB co-infected infants and children weighing >3 kg and ≤15 kg.

LPV/r will be administered as the liquid 80/20 mg/mL formulation (4:1 standard boosting ratio). During anti-TB treatment, additional RTV liquid formulation will be provided to deliver a 1:1 superboosting ratio of LPV to RTV. Actual doses for antiretrovirals and anti-TB drugs will be based on the South African (SA) weight band dosing recommendations and provided as per the site standard of care.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acquired Immunodeficiency Syndrome
  • Tuberculosis
  • Drug: lopinavir with ritonavir in 1:1 ratio
    During co-treatment of rifampicin containing tuberculosis treatment and lopinavir/ritonavir (4:1) based therapy, additional ritonavir is given to make lopinavir/ritonavir 1:1 ratio
    Other Names:
    • Lopinavir/ritonavir
    • Ritonavir
  • Drug: Lopinavir/ritonavir 4:1
    This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped
    Other Name: Lopinavir/ritonavir
Experimental: TB/HIV co-infection
Superboosting lopinavir with ritonavir in 1:1 ratio during TB/HIV co-infection and treatment of HIV with lopinavir/ritonavir 4:1
Interventions:
  • Drug: lopinavir with ritonavir in 1:1 ratio
  • Drug: Lopinavir/ritonavir 4:1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documentation of a confirmed diagnosis of HIV-1 infection following SA clinical guidelines
  • Weight >3kg ≤15 kg at enrolment
  • > 42 weeks gestational age
  • On LPV/r-based therapy or about to start a LPV/r-based antiretroviral combination therapy with 2 NRTIs [ABC+3TC or AZT+3TC or d4T+3TC]
  • Clinical diagnosis of TB requiring RIF-based therapy
  • Parent or legal guardian able and willing to provide written informed consent and able to attend study visits.

Exclusion Criteria:

  • For neonates, less than 42 weeks gestation and 14 days old
  • Concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . See Appendix E (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. Steroids)
  • Anticipation at the start that anti-TB treatment duration will be longer than 9 months
  • Any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (ALT) more than 10 times upper limit of normal (ULN), or chronic renal, hepatic or gastrointestinal disease such as malabsorption.
  • Children with known malignancies and contraindications to taking LPV/r
  • Treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT02348177
DNDiHIVPed001
Yes
Not Provided
Not Provided
Drugs for Neglected Diseases
Drugs for Neglected Diseases
  • University of Cape Town
  • Medecins Sans Frontieres, Netherlands
  • French Development Agency
  • UBS Optimus Foundation
Principal Investigator: Mark Cotton, Professor University of Stellenbosch
Drugs for Neglected Diseases
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP